Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00518453
First received: August 17, 2007
Last updated: November 4, 2011
Last verified: November 2011

August 17, 2007
November 4, 2011
July 2007
August 2007   (final data collection date for primary outcome measure)
evaluate the antibody response to each influenza vaccine antigen [ Time Frame: 21 days post-immunization ] [ Designated as safety issue: No ]
evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization
Complete list of historical versions of study NCT00518453 on ClinicalTrials.gov Archive Site
Safety and tolerability of the study vaccine in the study population [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Safety of a single intramuscolar injection
Not Provided
Not Provided
 
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
Experimental: Arm 1: Fluvirin
Intervention: Biological: Surface antigen inactivated influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

  • Any serious disease
Both
18 Years to 84 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00518453
V78P5S, 2007-002063-27
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP